Lupin gets US FDA approval for Cefdinir

Lupin Ltd has announced that the US Food and Drug Administration has approved its ''abbreviated new drug application'' (ANDA) for Cefdinir capsules 300mg. Cefdinir is a third generation cephalosporin administered orally to treat a wide variety of bacterial infections.

Cefdinir is being marketed by Abbott under the brand name Omnicef. As per IMS, the sales of the Omnicef franchise are $634 million (source: MAT, December 2005).

"The approval of our Cefdinir ANDA by the US FDA reinforces Lupin''s ability on submitting high quality dossiers and gaining approvals in time. This approval further widens the basket of products we offer in the largest generic market of the world and strengthens our position in the Cephalosporins business in the US," said Dr. Kamal Sharma, managing director, Lupin Ltd.

With this approval, Lupin now has 11 US FDA ANDAs approvals in hand.